Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE; HYDROCORTISONE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
NEOMYCIN SULPHATE; POLYMYXIN B SULPHATE; HYDROCORTISONE
5ml x 12 BOTTLE
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 POCIN H EAR DROPS Polymyxin B Sulphate / Neomycin Sulphate / Hydrocortisone (10000u / 3400u / 10mg) WHAT IS IN THE LEAFLET 1. What Pocin H is used for 2. How Pocin H works 3. Before you use Pocin H 4. How to use Pocin H 5. While you are using it 6. Side effects 7. Storage and Disposal of Pocin H 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT POCIN H IS USED FOR Pocin H is used to treat external ear canal infections and infections of cavity (middle ear) after ear operation (mastoidectomy). Your doctor may have prescribed Pocin H for another reason. Ask your doctor if you have any questions about why Pocin H has been prescribed for you. HOW POCIN H WORKS Pocin H contains the active ingredients, Polymyxin B sulphate, Neomycin sulphate and Hydrocortisone. Polymyxin B and Neomycin are antibiotics which helps to clear up infections. Hydrocortisone is a corticosteroid which helps to relieve inflammation and redness. BEFORE YOU USE POCIN H - _When you must not take it _ You must not use Pocin H if you have allergic reactions to Polymyxin B sulphate, Neomycin sulphate, Hydrocortisone or to any of the ingredients listed at the end of this leaflet. Do not use Pocin H if you are sensitive to one type of aminoglycoside or polymyxin as you may as well be sensitive to other types of aminoglycoside or polymyxin. Do not use this medicine if you have: • Bacterial infection of middle ear • Viral infection of ear • Fungal infection of ear • Perforated eardrum Do not use Pocin H after the expiry date printed on the pack. If you use this medicine after the expiry date has passed, it may not work as well. Do not use Pocin H if the packaging is torn or shows signs of tampering. - _Before you start to use it _ Tell your doctor if you have any allergies to any other medicines, foods or preservatives. Tell your doctor if you are pregnant, plan to become pregnant or breast-feeding. - _Taking other medicines _ Tell your doctor or ph Přečtěte si celý dokument
Pocin H ear drops should not be used in patients with a sensitivity to aminoglycside, polymyxins or sulphates. The use of Pocin H ear drops are also contraindicated in bullous myringitis, herpes simplex, herpes zoster oticus, tubercular or fungal infections of the ear, vaccinia, varicella, or other viral disease of the ear, chronic otitis media or perforated eardrum. Patients sensitive to one aminoglycoside or polymyxin may be sensitive to other aminoglycosides or polymyxins also. Risk of sensitization in relation to thiomersal and other preservatives. Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects. There is no relevant information available for neomycin, polymyxin B and hydrocortisone. _Pregnancy/Reproduction_ Topical corticosteroids have been shown to be teratogenic in rabbits when applied at concentration of 0.5% on days 6 to 18 of gestation and in mice when applied at a concentration of 15% on days 10 to 13 of gestation. (FDA Pregnancy Category C) No breast-feeding, paediatric and geriatric specific problems have been reported to date. 5ml x 12 bottles Store in a dry place below 30°C. For external use only. Discard contents 4 weeks after opening. Keep out of reach of children. _Jauhi daripada kanak-kanak._ Shelf life : Please refer to outer package. _Product Registration Holder:_ DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. Lot No. 2, 4, 6, 8, & 10, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. _Manufacturer:_ DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. Lot No. 2 & 4, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. DESCRIPTION POCIN H EAR DROPS POCIN H EAR DROPS PRECAUTIONS TOXICOLOGY A white to off-white, homogenous suspension. Ea Přečtěte si celý dokument